ACNE FIGHTING ROLL ON- salicylic acid gel
Greenbrier International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Salicylic acid 2%

Purpose
Acne treatment

Uses

for the treatment of acne

Warnings

For external use only

For adult use only

When using this product and other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Stop use and ask a doctor if irritation or redness develop.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, rinse thorougly with water.

Directions

Clean the skin thoroughly before applying this product
cover the entire affected area with a thin layer one to three times daily
because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other Information

Store at 20 degrees - 25 degrees C (68 degrees to 77 degrees F)

Inactive Ingredients
alcohol, allantoin, fragrance, glycerin, hydroxyethylcellulose, methylisothiazolinone, polysorbate 20, water.

DISTRIBUTED BY:

GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
MADE IN CHINA

Acne fighting Roll on Gel 9.4g

front

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ACNE FIGHTING ROLL ON
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33992-8815
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%) (UNII: 7Q6P4JN1QT)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape	ROUND	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-8815-1	9.4 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	07/15/2014	12/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	07/15/2014	12/31/2016

Labeler - Greenbrier International, Inc. (610322518)

Name	Address	ID/FEI	Business Operations
Establishment
Lab Douce Cosmetics (Shenzhen) Co., Ltd.		529303186	manufacture(33992-8815)

Revised: 4/2018

Document Id: 6ad7747a-84e1-025b-e053-2991aa0af914

Set id: 0ecda18a-8b6d-40dc-ac97-00073b422cc1

Version: 3

Effective Time: 20180427

Greenbrier International, Inc.